Diabetic Neuropathy, PainfulPhase 2PINBOTNCT05623111
Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities
A Phase 2 study testing Incobotulinumtoxin-A 100 UNIT Injection and Saline in people with Diabetic Neuropathy, Painful, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Neuropathy, Painful
- What is being tested?
- Incobotulinumtoxin-A 100 UNIT Injection and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Aug 2023to 1 Dec 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Are 18 years or older
- Are diagnosed with diabetes type I or II
- Score 3 or above on the Doleur Neuropathique 4 interview section
- Suffer from pain of the lower extremities which
- is considered by the participant as their dominant overall dominant pain
- is rated at least 4 out of 10 of the NRS pain scale in both legs (on average over the past 7 days)
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- is present in both feet, roughly symmetrically.
- has been present for at least 6 months
- Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40.
- Are in a stable analgesic treatment regime for at least 1 month prior to inclusion and for the duration of the study
- Are using an approved, safe contraceptive (for premenopausal women)
- Speak, read, and understand Danish
Who cannot join
- • Have a known allergy or hypersensitivity to BonT-A
- Have been treated with BonT in the last 6 months.
- Are diagnosed with myasthenia, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis
- Have a known malignant condition
- Have an ongoing infection in the area of injection
- Are expecting to change their pain medication during the study period
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- Have been treated with topical agents such as capsaicin or lidocaine products in the affected areas for at least 3 months prior to inclusion
- Are diagnosed with a competing cause of central or peripheral neuropathic pain, or other painful chronic conditions of the lower extremities, such as:
- spinal stenosis
- claudication
- previous trauma or nerve injury
- cancer related pain
- Have a psychiatric condition that affects their completion of the study, as assessed by the investigator.
- Are active abusers of alcohol or illegal substances
- Are using or receiving treatment with cannabis products of any kind
- Are pregnant or planning pregnancy during the study period
- Score more than 12 on the Charlson Comorbidity Index
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet Glostrup
Glostrup Municipality, 2600
Marc K Olsen, MD, marc.klee.olsen@regionh.dk
About this study
Official title: Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities: A Double-blind, Randomized, Placebo-controlled Study
The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs.
The main questions it aims to answer are:
- Is the treatment safe and effective?
- Does the treatment affect participants quality of life, depression, physical activity, daily life, and sensation?
Participants will be treated every 12 weeks, for a total of 24 weeks, with either incobotulinumtoxin-A or a placebo.
Read the detailed description
This study is a randomized, double-blind, placebo-controlled trial, investigating the safety, efficacy, use of rescue medication, and impact on NPSI scores, health-related QoL, activities of daily living (ADLs) and levels of physical activity of perineural incobotulinumtoxin-A (iBonT-A) or placebo injections, in persons with DNP of the lower extremities.
Participants will be randomly assigned via simple block randomization to receive either 100 units of iBonT-A in each leg (total of 200 units), or a placebo in each leg, injected perineurally around both distal sciatic nerves once every 12 weeks, for a total of 24 weeks.
Injections are performed with sonographic guidance by an experienced operator. Contents of the blinded vials, containing either 100 U of iBonT-A or a placebo consisting of small amounts of sucrose and albumin are diluted in 5 ml of sterile saline. The injection point is just distal to the sciatic nerve bifurcation. The skin is penetrated from the lateral side using a non-cutting needle (Pajunk, SonoBlock, 22G x 80 mm, Facet S Tip). With the needle in plane in relation to the ultrasound probe, the nerves are visualized in short axis. The needle tip is placed inside the common sheath surrounding the tibial and peroneus communis nerves. The location of the needle tip is verified with small boli of sterile saline solution in combination with ultrasound. Correct distribution of the injectant is confirmed with dynamic scanning. Fluid distention must be seen around both components. When confirmation of optimal needle placement the 100 units iBonT-A or placebo is injected. The procedure is repeated for both legs.
Participants will be asked to rate their neuropathic pain once a day, as well as register their daily use of rescue medication. Secondary outcome measures will be rated at baseline and at 4, 12, 16 and 24 weeks.
Safety information consists of adverse events recording, as well as motorfunction and sensory changes over time.
- Conditions
- Diabetic Neuropathy, Painful
- Being tested
- Incobotulinumtoxin-A 100 UNIT Injection, Saline
- Medical subject headings
- Diabetic Neuropathies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incobotulinumtoxin-A 100 UNIT InjectionDrug
Perineural injection
SalineDrug
Placebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline.
| Study group | Role | What they receive |
|---|---|---|
| Incobotulinumtoxin-A | Active comparator | 100 units of incobotulinumtoxin-A in 5ml of sterile saline around both distal ischial nerves. Receives: Drug: Incobotulinumtoxin-A 100 UNIT Injection |
| Placebo | Placebo comparator | 5ml sterile saline with small amounts of human albumin and sucrose (identical to binding agents in active vials) Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in daily neuropathic pain scores
Differences in pain scores, as measured by the Numeric Rating Scale (0-11), between groups.
Measured: Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Outcome is defined as differences in change from baseline of average daily and weekly pain scores between groups.
Secondary outcomes (9)
Use of rescue medication
Recorded using pain diary with simple Yes/No for use of any rescue medication. Changes in use of rescue medication over time and between groups.
Measured: Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Defined as differences in change from baseline of average days per week of rescue medication usage across the study period.
Neuropathic Pain Symptom Inventory
Changes in NPSI total and sub-scores over time and between groups.
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Health-related quality of life
EQ-5D-5L
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Activities of daily living
Canadian Occupational Outcome Measure (COPM)
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Physical activity
Grimby-Saltin Physical Activity Scale, Danish Version (PAS-2-DK)
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Depression symptoms
Beck Depression Inventory II (BDI-II)
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Adverse events
Incidence, severity and character of adverse, compared between active and placebo groups
Measured: Number and nature of adverse events compared between groups at 24 weeks.
Motorfunction of the lower legs.
Oxford MRC Muscle Power Assessment
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Sensory function
Sensation of the lower legs and feet, as measured by Quantitative Sensory Testing, according to the DFNS protocol.
Measured: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start1 Aug 2023
- Primary completion1 May 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetic Neuropathy, PainfulStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2-armed active/placebo 1:1 ratio
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH, Toyota Foundation Denmark, Steno Diabetes Center Zealand Region, Shipwright Per Henriksen, R., and wife Foundation, University of Copenhagen, Region Capital Denmark
- Responsible party
- Principal investigator, Bo Biering-Soerensen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Bo Biering-Sørensen, MD, Study director, Neurological Pain Clinic, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05623111
- Sponsor's protocol ID
- PINBOT
- Acronym
- PINBOT
- Status last verified
- Dec 2025
- First submitted
- 31 Oct 2022
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study data will be published in anonymised format as supplementary material to publications. Study protocol, SAP, ICH And analytic code available upon request.
Publications
Klee M, Hormann Thomsen T, Enggaard TP, Bitsch MS, Simonsen L, Jensen RH, Biering-Sorensen B. Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: protocol for a phase II, single-centre, double-blind, randomised, placebo-controlled trial (the PINBOT study). BMJ Open. 2024 Jan 22;14(1):e074372. doi: 10.1136/bmjopen-2023-074372.
PubMed 38262642
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Injections of Incobotulinumtoxin-A for Diabetic Neuropathic Pain of the Lower Extremities: A Double-blind, Randomized, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT05623111
- Acronym / sponsor ID
- PINBOT / PINBOT
- Conditions
- Diabetic Neuropathy, Painful
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Merz Pharmaceuticals GmbH, Toyota Foundation Denmark, Steno Diabetes Center Zealand Region, Shipwright Per Henriksen, R., and wife Foundation, University of Copenhagen, Region Capital Denmark
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 1 May 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 21 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to test perineural injections (injections around a nerve) of incobotulinumtoxin-A in participants with diabetic nerve pain of the feet and lower legs.
The main questions it aims to answer are:
- Is the treatment safe and effective?
- Does the treatment affect participants quality of life, depression, physical activity, daily life, and sensation?
Participants will be treated every 12 weeks, for a total of 24 weeks, with either incobotulinumtoxin-A or a placebo.
Detailed description
This study is a randomized, double-blind, placebo-controlled trial, investigating the safety, efficacy, use of rescue medication, and impact on NPSI scores, health-related QoL, activities of daily living (ADLs) and levels of physical activity of perineural incobotulinumtoxin-A (iBonT-A) or placebo injections, in persons with DNP of the lower extremities.
Participants will be randomly assigned via simple block randomization to receive either 100 units of iBonT-A in each leg (total of 200 units), or a placebo in each leg, injected perineurally around both distal sciatic nerves once every 12 weeks, for a total of 24 weeks.
Injections are performed with sonographic guidance by an experienced operator. Contents of the blinded vials, containing either 100 U of iBonT-A or a placebo consisting of small amounts of sucrose and albumin are diluted in 5 ml of sterile saline. The injection point is just distal to the sciatic nerve bifurcation. The skin is penetrated from the lateral side using a non-cutting needle (Pajunk, SonoBlock, 22G x 80 mm, Facet S Tip). With the needle in plane in relation to the ultrasound probe, the nerves are visualized in short axis. The needle tip is placed inside the common sheath surrounding the tibial and peroneus communis nerves. The location of the needle tip is verified with small boli of sterile saline solution in combination with ultrasound. Correct distribution of the injectant is confirmed with dynamic scanning. Fluid distention must be seen around both components. When confirmation of optimal needle placement the 100 units iBonT-A or placebo is injected. The procedure is repeated for both legs.
Participants will be asked to rate their neuropathic pain once a day, as well as register their daily use of rescue medication. Secondary outcome measures will be rated at baseline and at 4, 12, 16 and 24 weeks.
Safety information consists of adverse events recording, as well as motorfunction and sensory changes over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- 2-armed active/placebo 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Incobotulinumtoxin-A | Active comparator | Drug: Incobotulinumtoxin-A 100 UNIT Injection100 units of incobotulinumtoxin-A in 5ml of sterile saline around both distal ischial nerves. |
| Placebo | Placebo comparator | Drug: Saline5ml sterile saline with small amounts of human albumin and sucrose (identical to binding agents in active vials) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Are 18 years or older
- Are diagnosed with diabetes type I or II
- Score 3 or above on the Doleur Neuropathique 4 interview section
- Suffer from pain of the lower extremities which
- Show sensory deficits and/or allodynia or hyperalgesia in the painful area, consistent with the IASP definition of probable chronic neuropathic pain40.
Key exclusion criteria (17 listed)
- • Have a known allergy or hypersensitivity to BonT-A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incobotulinumtoxin-A 100 UNIT InjectionPerineural injection | Drug | Incobotulinumtoxin-A |
| SalinePlacebo containing trace amounts of human albumin and sucrose, diluted with 5ml of sterile saline. | Drug | Placebo |
Primary outcome
Changes in daily neuropathic pain scores
Time frame: Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Outcome is defined as differences in change from baseline of average daily and weekly pain scores between groups.
Differences in pain scores, as measured by the Numeric Rating Scale (0-11), between groups.
9 secondary outcomes
Use of rescue medication
Time frame: Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Defined as differences in change from baseline of average days per week of rescue medication usage across the study period.
Neuropathic Pain Symptom Inventory
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Health-related quality of life
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Activities of daily living
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Physical activity
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Depression symptoms
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Adverse events
Time frame: Number and nature of adverse events compared between groups at 24 weeks.
Motorfunction of the lower legs.
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Sensory function
Time frame: Baseline, 4 weeks, 12 weeks, 16 weeks, 24 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Derived from this study: PubMed 38262642Klee M, Hormann Thomsen T, Enggaard TP, Bitsch MS, Simonsen L, Jensen RH, Biering-Sorensen B. Perineural injections of incobotulinumtoxin-A for diabetic neuropathic pain of the lower extremities: protocol for a phase II, single-centre, double-blind, randomised, placebo-controlled trial (the PINBOT study). BMJ Open. 2024 Jan 22;14(1):e074372. doi: 10.1136/bmjopen-2023-074372.
- Individual participant dataSharing planned: Yes. Study data will be published in anonymised format as supplementary material to publications. Study protocol, SAP, ICH And analytic code available upon request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bo Biering-Sørensen, MD study director
Neurological Pain Clinic, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Incobotulinumtoxin-A 100 UNIT Injection and Saline in people with Diabetic Neuropathy, Painful, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marc Klee Olsen, MD (+4538633030, marc.klee.olsen@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in daily neuropathic pain scores (time frame: Recorded once daily for 1 week prior to first injection and daily for the duration of the study. Outcome is defined as differences in change from baseline of average daily and weekly pain scores between groups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05623111, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.